INTERGROUP TRIAL FOR CHILDREN OR ADOLESCENTS WITH B-CELL NHL OR B-AL: EVALUATION OF RITUXIMAB EFFICACY AND SAFETY IN HIGH RISK PATIENTS

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

HISTOLOGY AND STAGING DISEASE, Phase III study: , -Histologically or
cytologically proven B-cell malignancies, either Burkitt lymphoma or B-AL
(<=Burkitt leukaemia <= L3-AL) or diffuse large B-cell NHL or aggressive mature
B-cell NHL non other specified or specifiable., -Stage III with elevated LDH
level (*B-high*), [LDH > twice the institutional upper limit of the adult
normal values (> Nx2)] or any stage IV or B-AL., Phase II study: ,
-Histolo-cytologically proven PMLBL. , -PMLBL without CNS involvement., GENERAL
CONDITIONS, -6 months to less than 18 years of age at the time of consent.,
-Males and females of reproductive potential must agree to use an effective
contraceptive method during the treatment, and after the end of treatment:
during twelve months for women, taking into account the characteristics of
rituximab and during five months for men, taking into account the
characteristics of methotrexate., INITIAL WORK-UP, -Complete initial work-up
within 8 days prior to treatment., OTHERS, -Able to comply with scheduled
follow-up and with management of toxicity., -Signed informed consent from
patients and/or their parents or legal guardians.

Exclusion Criteria

-Follicular lymphoma, MALT and nodular marginal zone are not included into this
therapeutic study., -In phase II study (PMLBL) patients with CNS involvement
are not eligible., -Patients with congenital immunodeficiency, chromosomal
breakage syndrome, prior organ transplantation, previous malignancy of any
type, or known positive HIV serology., -Evidence of pregnancy or lactation
period., -There will be no exclusion criteria based on organ function., -Past
or current anti-cancer treatment except corticosteroids of less than, 7 days
duration in total., -Tumor cell negative for CD20 (absence of result due to
technical problems in the presence of other characteristics suggestive of
BL/DLBCL, including genetic and phenotypic features, is not an exclusion
criteria) , -Prior exposure to rituximab., -Severe active viral infection,
especially hepatitis B. Severe infection (such as sepsis, pneumonia, etc..)
should be clinically controlled at the time of randomisation. Contact the
national co-investigator for further advice if necessary., - Hepatitis B
carrier status history of HBV or positive serology

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>Event Free Survival (EFS): Minimum time to death from any cause, presence of<br /><br>viable cells<br /><br>in residue after 6th DA-EPOCH course, relapse, progressive<br /><br>disease, or second malignancy measured from registration.</p><br>

Secondary Outcome Measures

Name	Time	Method

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